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Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus.

Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus.

Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the blastocyst stage of development. This medium can be used for transfer of blastocyst stage embryos into the uterus.

Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus.

Gems VitBase is used to maintain embryos for a short period of time in a non-gassed environment during embryo vitrification and warming procedures. The embryos can be placed in this medium for a maximum of 10 minutes.

The subject devices are culture media consisting of salts, energy substrates, amino acids, buffering agents, nutrients supplements and antibiotics, with or without L-Carnitine and/or human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures in a hospital environment. These media are single-use devices that are aseptically filled into the sterilized bottles and have a sterility assurance level (SAL) of 10-3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.

This document describes the Genea Biomedx Genea Embryo Culture Media and its associated performance testing for substantial equivalence to predicate devices, as reviewed by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several key parameters are presented, primarily for shelf-life studies and comparison to predicate devices/literature.

2. Sample Sizes Used for the Test Set and Data Provenance

A single-site clinical trial was conducted for performance testing.

• Test Set Sample Size:
  • Embryos:
    • Test Group (Subject Devices): 641 embryos used
    • Control Group (Genea in-house media): 598 embryos used
  • Embryo Transfer Procedures:
    • Test Group: 569 procedures
    • Control Group: 531 procedures
  • The sample sizes for MEA, endotoxin, sterility, and biocompatibility tests are not explicitly stated, but standard procedures typically involve sufficient numbers for statistical validity.
• Data Provenance: The clinical trial was conducted at the Genea Clinic (Sydney, Australia). The study was prospective as it was a controlled, double-blinded, single-site clinical trial designed to evaluate safety and effectiveness.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts involved in establishing the ground truth for the clinical trial endpoints (pregnancy rate, fertilization rate, cleavage rate, blastulation rate, live birth rate). These outcome measures are typically objectively determined through established medical protocols and laboratory analyses in an IVF clinic setting. The "ground truth" for clinical outcomes in this context would be the objective clinical data recorded (e.g., ultrasound confirmation of fetal heartbeat, successful fertilization observed microscopically, embryo development stages).

4. Adjudication Method for the Test Set

The document states it was a "controlled, double-blinded, single-site clinical trial." This implies that neither the patients nor the clinicians/researchers directly involved in assessing outcomes were aware of whether the specific subject device or the control media was used. This blinding inherently serves as a form of adjudication against bias in outcome assessment. However, a specific "adjudication method" (like 2+1 reads for imaging) is not applicable or described for these types of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a direct output. This document describes embryo culture media, and its effectiveness is measured by biological outcomes, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a "Reproductive Media and Supplements" – an in-vitro diagnostic/culture medium, not an algorithm or AI device. Its performance is inherent to its biochemical properties and biological effect on embryos, assayed through laboratory and clinical endpoints.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on:

• Outcomes Data:
  • Primary Endpoint: Fetal heartbeat at 6-8 weeks post-embryo transfer (objective clinical outcome).
  • Secondary Endpoints: Fertilization rate, cleavage rate, and blastulation rate (observable biological outcomes assessed in the lab).
  • Additional Analysis: Live birth rate (objective clinical outcome).
• Comparative Data: The study compared its clinical outcomes to:
  • Published literature for fertilization, cleavage, and blastulation rates.
  • Assisted Reproductive Technology National Summary Report published by the Centers for Disease Control and Prevention (CDC) for pregnancy and live birth rates.
  • Genea in-house media in the control group for direct comparison within the trial.

8. The Sample Size for the Training Set

This information is not provided. The document describes pre-market notification (510(k)) for substantial equivalence, which focuses on demonstrating safety and effectiveness for a device, typically through testing and comparison, rather than an "algorithm training" process. The media formulations and manufacturing processes would have been developed and optimized, but not necessarily through a formal "training set" in the sense of machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As mentioned above, the concept of a "training set" with established "ground truth" in the statistical learning sense is not directly applicable to the development of embryo culture media as described in this document. The development and optimization of such media would involve extensive R&D, experimentation, and quality control, ensuring optimal conditions for embryo development, but this is distinct from establishing ground truth for a machine learning model.

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